Quantum

FDA UDI

Class I (US FDA UDI)

by In2bones

Identity

Trade Name: QUANTUM FDA UDI
Generic Name: Osteotomy guide, reusable FDA UDI
Device Name: QUANTUM Resection Guide For Talar Chamfer S5 FDA UDI
Model / Reference: M05 01021 FDA UDI
Description: QUANTUM Resection Guide For Talar Chamfer S5 FDA UDI

Identifiers

Catalog Number: M05 01021 FDA UDI
Primary DI / UDI-DI: 03701337601140 FDA UDI
510(k) Number: K191380 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Osteotomy guide, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 70.18 Millimeter FDA UDI
Width — 34.26 Millimeter FDA UDI

Category: Osteotomy guide, reusable

Quantum by In2bones — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Osteotomy guide, reusable.

Legion — Smith & Nephew, Inc. · Class II
MOBIO™ Total Knee System — b-ONE Ortho Corp. · Class II
Persona® — Zimmer, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class I
Profix — Smith & Nephew, Inc. · Class II
Cut Guide — TREACE MEDICAL CONCEPTS, INC. · Class I
UKNEE™ — UNITED ORTHOPEDIC CORP. · Class I
Truliant CC — Exactech, Inc. · Class II

Cleared under the same submission

K191380 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: In2bones

Sources (1)

FDA UDI d3b230ed-2218-497c-9b97-82576693710e 37 fields · synced Jun 8, 2026